Adaptive Design for the FDA’s RSABE? [Two-Stage / GS Designs]

posted by Helmut Homepage – Vienna, Austria, 2023-12-18 12:20 (349 d 09:58 ago) – Posting: # 23794
Views: 4,904

Dear all,

I stumbled across this (goody ?):

An adaptive trial design for testing the
bioequivalence of generics of highly
variable drugs

Seemingly1 a well-known framework2 is followed with Pocock’s \(\small{\alpha_\text{adj}=0.0294}\) (for superiority – the correct one for equivalence is \(\small{0.0304}\)…).
I don’t have the paper yet (behind a paywall) but I have some doubts that the method is well thought out:To summarize:
  1. Lim D, Rantou E, Kim J, Choi S, Choi NH, Grosser S. Adaptive designs for IVPT data with mixed scaled average bioequivalence. Pharm Stat. 2023; 22(6): 1116–34. doi:10.1002/pst.2333.
  2. Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008; 7(4): 245–62. doi:10.1002/pst.294. [image] Open access.
  3. Tóthfalusi L, Endrényi L. Sample Sizes for Designing Bioequivalence Studies for Highly Variable Drugs. J Pharm Phar­ma­ceut Sci. 2012; 15(1): 73–84. doi:10.18433/J3Z88F. [image] Open access.
  4. Schütz H, Labes D, Wolfsegger MJ. Critical Remarks on Reference-Scaled Average Bioequivalence. J Pharm Pharmaceut Sci. 2022; 25: 285–96. doi:10.18433/jpps32892. [image] Open access.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
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